Pump apparatus and methods for expression of human breast milk

ABSTRACT

Improved devices, systems and methods for the expression of milk from a breast are disclosed herein. A device for expression of milk may comprise a peristaltic pump configured to move a fluid to or from a breast interface, so as to apply pressure at the breast interface and thereby express milk from the breast. The peristaltic pump can be removably coupled to a tube carrying the fluid, so as to maintain a separation between the peristaltic pump and the fluidly coupled components of the device. A device for expressing breast milk may further comprise an adjustable breast interface configured to engage and fluidly seal against the human breast. The adjustable breast interface may be manually or automatically adjustable to fluidly seal against a plurality of sizes or shapes of human breasts.

CROSS-REFERENCE

This application claims the benefit of U.S. Provisional Application No.62/021,601, filed Jul. 7, 2014 [Attorney Docket No. 44936-705.101] andU.S. Provisional Application No. 62/028,219, filed Jul. 23, 2014[Attorney Docket No. 44936-708.101], the full disclosures of which areincorporated herein by reference.

This application is related to U.S. patent application Ser. No.14/221,113, filed on Mar. 20, 2014 [Attorney Docket No. 44936-703.201],U.S. patent application Ser. No. 14/616,557, filed on Feb. 6, 2015[Attorney Docket No. 44936-704.201], U.S. Provisional Application No.62/021,597, filed on Jul. 7, 2014 [Attorney Docket No. 44936-706.101],and U.S. Provisional Application No. 62/021,604, filed Jul. 7, 2014[Attorney Docket No. 44936-707.101], the full disclosures of which areincorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to medical devices and methods,and more particularly relates to devices and methods for expression andcollection of human breast milk.

The exemplary embodiments disclosed herein are preferably directed atexpression of breast milk, but one of skill in the art will appreciatethat this is not intended to be limiting and that the devices, systemsand methods disclosed herein may be used for other treatments requiringapplication of a differential pressure. The devices, systems and methodsdisclosed herein may be used for treatments requiring application of adifferential pressure to a patient or work surface, with a device havingan adjustable flange that can accommodate varying patient anatomy orvarying work surfaces.

Breast pumps are commonly used to collect breast milk in order to allowmothers to continue breastfeeding while apart from their children.Currently, there are two primary types of breast pumps:manually-actuated devices, which are small, but inefficient and tiringto use; and electrically-powered devices, which are efficient, but largeand bulky. Therefore, it would be desirable to provide improved breastpumps that are small and highly efficient for expression and collectionof breast milk. Additionally, current and proposed pump systems may onlyactuate a single breast pump, and therefore it would be advantageous toprovide a pump that can actuate two breast pumps simultaneously.

Further, currently existing or proposed breast pumps may only providebreast interfaces of limited, fixed sizes, which can result in usershaving to purchase and return multiple parts as well as contend withpoor fit and inefficient pumping. Breast pump users comprise apopulation with a wide range of size and shape requirements, which mayalso change over the course of use of the breast pump due to the effectsof sustained use of the pump or due to natural changes in user anatomiesthroughout the course of breastfeeding. Therefore, it would be desirablefor a breast pump to provide a breast interface that is adjustable insize or shape. At least some of these objectives will be satisfied bythe devices and methods disclosed below.

2. Description of the Background Art

The following US patents are related to expression and collection ofhuman breast milk: U.S. Pat. Nos. 6,673,036; 6,749,582; 6,840,918;6,887,210; 7,875,000; 8,118,772; and 8,216,179. U.S. Patent PublicationNo. 2014/0121593 also relates to expression and collection of breastmilk.

SUMMARY OF THE INVENTION

The present invention generally relates to medical devices, systems andmethods, and more particularly relates to devices, systems and methodsfor expression and collection of human breast milk.

Disclosed herein are small and highly efficient apparatuses and methodsof use for expression and collection of breast milk. An apparatus forexpression of milk as described herein may comprise a hydraulic system,wherein movement of a fluid to or from a breast interface can applypressure at the breast interface and thereby express milk from thebreast engaged thereto. The apparatus may comprise a peristaltic pumpthat is removably coupled to a tube carrying the fluid, so as to movethe fluid to or from the breast interface while maintaining a separationbetween the peristaltic pump and the fluidly coupled components of theapparatus.

Also disclosed herein are methods and apparatus for providing anadjustable breast interface to accommodate a range of size and shaperequirements of the users. The adjustable breast interface may comprisean adjustable flange configured to engage and seal against the breast,wherein the adjustable flange may be adjusted in one or both of thefrustoconical portion and the inner diameter of the tubular flange neck.Alternatively or in combination, the adjustable breast interface maycomprise an adjustable expression area, whose size and/or shape may beadjusted by adjusting a volume of an expression reservoir of the breastinterface. For example, the expression reservoir may be fluidly coupledto an adjustable reservoir and an actuatable assembly, wherein a volumeof the adjustable reservoir may be manually or automatically adjusted toadjust the volume of the expression reservoir and hence the size of theexpression area.

In a first aspect, a device for expression and collection of breast milkcomprises a breast interface configured to engage a breast and fluidlyseal thereagainst, the breast interface having a movable member disposedwithin at least a portion thereof. The device further comprises a tubefilled with fluid and fluidly coupled with the breast interface, and aperistaltic pump coupled with the tube, wherein actuation of theperistaltic pump moves the fluid in a first direction or a seconddirection opposite the first direction. Movement of the fluid in thefirst direction moves the movable member in the breast interface in thefirst direction and thereby causes the breast interface to apply vacuumpressure at the breast to express milk therefrom. Movement of the fluidin the second direction moves the movable member in the breast interfacein the second direction and thereby applies pressure at the breastinterface. The peristaltic pump may be removably coupled with the tube.

The movable member of the breast interface may comprise one or more of aflexible membrane, a deformable portion of a sealing element coupled toa flexible membrane, or an expandable membrane, configured to move inresponse to actuation of the peristaltic pump. Movement of the movablemember in the second direction may return the breast interface toatmospheric pressure, thereby allowing the expressed milk to drain intoa collection vessel coupled to the breast interface. The device mayfurther comprise a collection vessel fluidly coupled to the breastinterface, and movement of the movable member in the second directionmay apply positive pressure at breast interface, thereby forcing theexpressed milk out of breast interface into the collection vessel.

The device may further comprise a collection vessel fluidly coupled tothe breast interface, and the breast interface may comprises a firstbreast interface configured to engage a first breast and a second breastinterface configured to engage a second breast. Actuation of theperistaltic pump may simultaneously cause the first breast interface toexpress milk from the first breast and the second breast interface tocollect expressed milk from the second breast into the collectionvessel.

The tube may comprise a central compliant region configured to engagethe peristaltic pump. The tube may further comprise a less compliantregion that is less compliant relative to the central compliant regionand disposed adjacent to the central compliant region. The centralcompliant region may compress in response to actuation of theperistaltic pump, while the less compliant region may transmit pressurealong the tube to the breast interface.

In another aspect, a method for expressing milk from a breast comprisesengaging and fluidly sealing a breast interface with the breast,actuating a peristaltic pump, and expressing milk from the breast. Theperistaltic pump may be coupled with a tube filled with a fluid andfluidly coupled to the breast interface, such that actuation of theperistaltic pump can apply vacuum pressure at the breast to express milkfrom the breast.

Actuating a peristaltic pump may comprise actuating the peristaltic pumpso as to move the fluid in a first direction or in a second directionopposite the first direction. Moving the fluid in the first directionmay cause a movable member within the breast interface to move away fromthe breast and thereby apply vacuum pressure at the breast to expressmilk therefrom. Moving the fluid in the second direction may cause themovable member to move toward the breast and thereby cause the expressedmilk to drain into a collection vessel fluidly coupled to the breastinterface. Moving the fluid in the second direction may return thebreast interface to atmospheric pressure, thereby allowing the expressedmilk to drain into the collection vessel. Alternatively or incombination, moving the fluid in the second direction may apply apositive pressure at breast interface, thereby forcing the expressedmilk out of the breast interface into the collection vessel.

The breast interface may comprise a first breast interface configured toengage a first breast and a second breast interface configured to engagea second breast. Actuating a peristaltic pump may comprisesimultaneously moving the fluid away from the first breast interface toexpress milk from the first breast, and moving the fluid toward thesecond breast interface to collect expressed milk from the second breastinto a collection vessel fluidly coupled to the second breast interface.

In another aspect, a device for expressing breast milk from a breastcomprises a breast interface comprising a flange configured to engageand fluidly seal against the breast, and an expression area where milkis expressed from the breast. The breast interface is manually orautomatically adjustable to fluidly seal against a plurality of sizes orshapes of breasts.

The flange may comprise one or more resilient materials conformable tothe breast and adapted to fluidly seal against the plurality of sizes orshapes of breasts. The flange may further comprise a pocket fillablewith a filling material, wherein addition of filling material to, orremoval of the filling material from the pocket adjusts a size of theflange. The filling material may comprise a plurality of bead-likeelements, wherein application of a vacuum to the pocket substantiallylocks the plurality of bead-like elements and the flange into a fixedconfiguration for fluidly sealing against a particular size or shape ofhuman breast. Alternatively or in combination, the filling material maycomprise a fluid. The breast interface may further comprise a fluid pumpfluidly coupled to the pocket, the fluid pump configured to add orremove the fluid from the pocket.

The device may further comprise an actuatable assembly operativelycoupled to the breast interface, an expression reservoir disposed withinthe breast interface, and an adjustable reservoir fluidly coupled to theexpression reservoir and operatively coupled to the actuatable assembly.The actuatable assembly may be configured to deliver fluid from theadjustable reservoir to the expression reservoir or remove fluid fromthe expression reservoir and return the fluid to the adjustablereservoir. The adjustable reservoir may comprise a mechanism to adjust avolume thereof, so as to adjust a volume of the expression reservoir andthereby adjust a size of the expression area to fluidly seal against aparticular size or shape of breast.

The mechanism may be manually adjustable. Alternatively or incombination, the mechanism may be automatically adjustable, to adjustthe volume of the adjustable reservoir in response to a feedback fromthe actuatable assembly indicating a degree of fluid seal between thebreast interface and the breast. The feedback may comprise a currentproduced by the actuatable assembly as the volume of the adjustablereservoir is adjusted, wherein an increase in the current indicates anincreased degree of fluid seal between the breast interface and thebreast. The adjustable reservoir may be integrated with the actuatableassembly, such that the volume of the adjustable reservoir may beadjusted by changing a setting of the actuatable assembly. For example,the actuatable assembly may comprise a piston assembly, and theadjustable reservoir may comprise a reservoir of the piston assembly,such that changing a resting position of the piston assembly adjusts thevolume of fluid in the adjustable reservoir.

In another aspect, a method for expressing breast milk from a breastcomprises providing a device for expressing breast milk comprising anadjustable breast interface having a flange and an expression area. Themethod further comprises engaging the adjustable breast interface withthe breast, adjusting a size of the adjustable breast interface, fluidlysealing the breast interface against the breast, and expressing milkfrom the breast.

Adjusting the size of the adjustable breast interface may compriseadding a fluid to or removing the fluid from a pocket disposed withinthe flange. Alternatively or in combination, adjusting the size of theadjustable breast interface may comprise providing a plurality ofbead-like elements disposed in a pocket in the flange. The method mayfurther comprise molding the plurality of bead-like elements against thehuman breast, applying a vacuum to the pocket, and locking the flangeinto a particular size or shape.

The breast interface may comprise an expression reservoir fluidlycoupled with an actuatable assembly and an adjustable reservoir.Adjusting the size of the adjustable breast interface may compriseactuating the actuatable assembly, thereby delivering a fluid from theadjustable reservoir to the expression reservoir or removing the fluidfrom the expression reservoir and returning the fluid to the adjustablereservoir. The method may further comprise adjusting a volume of theadjustable reservoir so as to adjust a volume of the expressionreservoir, thereby adjusting a size of the expression area. Adjusting avolume of the adjustable reservoir may comprise manually adjusting thevolume of the adjustable reservoir. Alternatively or in combination,adjusting a volume of the adjustable reservoir may compriseautomatically adjusting the volume of the adjustable reservoir inresponse to a feedback from the actuatable assembly indicating a degreeof fluid seal between the breast interface and the breast. Theadjustable reservoir may be integrated with the actuatable assembly, andautomatically adjusting the volume of the adjustable reservoir maycomprise changing a setting of the actuatable assembly. For example, theactuatable assembly may comprise a piston assembly and the adjustablereservoir may comprise a reservoir of the piston assembly, whereinautomatically adjusting the volume of the adjustable reservoir compriseschanging a resting position of the piston assembly.

These and other embodiments are described in further detail in thefollowing description related to the appended drawing figures.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 is a perspective view of an exemplary embodiment of a pumpingdevice.

FIG. 2 is a perspective view of an exemplary embodiment of a pumpingdevice.

FIG. 3A is a cross-section of an exemplary embodiment of a pumpingdevice.

FIG. 3B is a cross-section of an exemplary embodiment of a pumpingdevice.

FIG. 4 illustrates an exemplary embodiment of an actuatable assemblycoupled to a driving mechanism.

FIGS. 5A-5B illustrate an exemplary embodiment of an actuatable assemblycoupled to a pendant unit.

FIG. 6 is a cross-sectional view of an exemplary embodiment of a breastinterface.

FIG. 7 is a cross-sectional view of another exemplary embodiment of abreast interface.

FIG. 8A is a cross-sectional view of an exemplary embodiment of anintegrated valve in an open position.

FIG. 8B is a cross-sectional view of an exemplary embodiment of anintegrated valve in a closed position.

FIG. 9A is a cross-sectional view of an exemplary embodiment ofintegrated sensors within a breast interface.

FIG. 9B is a cross-sectional view of another exemplary embodiment ofintegrated sensors within a breast interface.

FIG. 10 illustrates an exemplary embodiment of a pendant unit and amobile device.

FIG. 11 illustrates an exemplary embodiment of a pendant unit incommunication with a mobile device.

FIG. 12 is a cross-sectional view of an exemplary embodiment of a breastinterface with a mechanical deformable member.

FIG. 13 is a cross-sectional view of an exemplary embodiment of amechanical driver for a mechanical deformable member.

FIG. 14 is a graph illustrating the pump performance of an exemplaryembodiment compared to a commercial device.

FIG. 15 is a graph illustrating the pumping efficiency of an exemplaryembodiment compared to a commercial device.

FIG. 16 illustrates an exemplary pump.

FIG. 17 illustrates a cross-section of the pump in FIG. 16.

FIG. 18 illustrates an alternative embodiment of a pump system.

FIG. 19A is a cross-sectional view of an exemplary embodiment of anadjustable flange 1600.

FIGS. 19B and 19C illustrate exemplary embodiments of adjustable flangesof different sizes.

FIGS. 20A and 20B are perspective views of an exemplary embodiment of anadjustable flange with a sizing element.

FIGS. 21A, 21B, and 21C are cross-sectional views of an exemplaryembodiment of an adjustable flange with a sizing element.

FIGS. 22A, 22B, and 22C illustrate exemplary embodiments of anadjustable flange that comprises a fillable pocket.

FIG. 22D is a cross-sectional view of an exemplary embodiment of anadjustable flange with a pocket filled with a fluid.

FIG. 22E is a cross-sectional view of an exemplary embodiment of anadjustable flange with a pocket filled with a plurality of bead-likeelements.

FIGS. 23A and 23B illustrate an exemplary embodiment of an adjustableflange that comprises a fillable pocket.

FIGS. 24A and 24B illustrate an exemplary embodiment of a device forexpressing breast milk comprising an adjustable expression area.

FIG. 25 illustrates an exemplary embodiment of an automaticallyadjustable system for adjusting the size of the expression area.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the disclosed devices and methods will now bedescribed with reference to the drawings. Nothing in this detaileddescription is intended to imply that any particular component, feature,or step is essential to the invention. One of skill in the art willappreciate that various features or steps may be substituted or combinedwith one another.

The present invention will be described in relation to the expressionand collection of breast milk. However, one of skill in the art willappreciate that this is not intended to be limiting, and the devices andmethods disclosed herein may be used in other applications involving thecreation and transmission of a pressure differential, such as in thetreatment of sleep apnea, wound compression, and/or other remotepressure needs, and where it would be desirable to provide an adjustableflange that can fluidly seal against a variety of anatomical shapes andsizes or any other varying work surface.

FIG. 1 illustrates an exemplary embodiment of a breast pump. Pumpingdevice 100 includes breast interfaces 105, a tube 110, and a controlleror pendant unit 115 operatively coupled to breast interfaces 105 throughtube 110. Breast interfaces 105 include resilient and conformableflanges 120, for engaging and creating a fluid seal against the breasts,and collection vessels 125. The device may optionally only have a singlebreast interface. Pendant unit 115 houses the power source and drivemechanism for pumping device 100, and also contains hardware for variousfunctions, such as controlling pumping device 100, milk productionquantification and content analysis, and communication with otherdevices. Tube 110 transmits suitable energy inputs, such as mechanicalenergy inputs, from pendant unit 115 over a long distance to breastinterfaces 105. Breast interfaces 105 convert the energy inputs intovacuum pressure against the breasts in a highly efficient manner,resulting in the expression of milk into collection vessels 125.

One of skill in the art will appreciate that components and features ofthis exemplary embodiment can be combined or substituted with componentsand features of any of the embodiments of the present invention asdescribed below. Similarly, components and features of other embodimentsdisclosed herein may be substituted or combined with one another.

Hydraulic Pumping Device

Hydraulic systems can reduce pumping force requirements, and thereforealso reduce the size of the pumping device, while maintaining highpumping efficiency. In a preferred embodiment, the pumping device canutilize a hydraulic pumping device to generate a pressure differentialagainst the breast for the expression and collection of milk.

Exemplary hydraulic pumping devices are depicted in FIGS. 2 and 3. FIG.2 illustrates a pumping device 150 with a syringe 155 fluidly coupled tobreast interface 160 by tube 165. Syringe 155 is coupled to tube 165through a three-way valve 170. Breast interface 160 contains an exitport 175. The syringe 155 drives a fluid 180 contained within tube 165against or away from an expandable member contained within breastinterface 160 to create the pressure differential necessary for milkexpression from the breast.

FIG. 3A illustrates another embodiment of a pumping device 200. Theactuatable assembly 205 includes an assembly housing 210, a drivingelement 215, radial seals 220, and a shaft 222. Driving element 215 isoperatively coupled to a pendant unit, such as pendant unit 115, throughshaft 222. The tube 225 contains a fluid 230 and is fluidly coupled tothe actuatable assembly 205 and the breast interface 235. The breastinterface 235 consists of an interface housing 240, a flexible membrane245, a reservoir 250, a sealing element 255, an expression area 260, anda drain port 265. The sealing element 255 includes deformable portion270. The drain port 265 is coupled to a collection vessel 275 andincludes a one-way valve 280 which may be a flap, duckbill, or ballvalve.

Actuatable assembly 205 displaces fluid 230 contained within tube 225,which can be a flexible line. Fluid 230 occupies reservoir 250 withinbreast interface 235 and is coupled with flexible membrane 245. Flexiblemembrane 245 transmits vacuum pressure from fluid 230 to the deformableportion 270 of sealing element 255. The flexible membrane 245 anddeformable portion 270 are movable so as to move toward and away fromthe breast as the actuatable element 215 is actuated. When a breast isengaged into and fluidly sealed with breast interface 235 by sealingelement 255, displacement of the actuatable element 215 in the outwarddirection away from the breast produces substantial vacuum pressureagainst the breast through flexible membrane 245 and deformable portion270, resulting in the expression of breast milk into expression area260. The expressed milk drains through drain port 265 into collectionvessel 275. Drain port 265 is configured with a one-way valve 280 toprovide passage of milk while maintaining vacuum pressure in expressionarea 260.

FIG. 3B illustrates another exemplary embodiment of a pumping device 200a. The actuatable assembly 205 includes an assembly housing 210, adriving element 215, radial seals 220, and a shaft 222. Driving element215 is operatively coupled to a pendant unit, such as pendant unit 115,through shaft 222. The tube 225 contains a fluid 230 and is fluidlycoupled to the actuatable assembly 205 and the breast interface 235 a.The breast interface 235 a comprises a flange 236, an interface housing240, an expandable membrane 245 a, an expression reservoir 250, anexpression area 260, and a drain port 265. The flange 236 comprises afrustoconical portion 237 and a tubular flange neck 238. The flange neckconnects to the expression area through the expression mouth 261. Thedrain port 265 is coupled to a collection vessel 275 and includes aone-way valve 280.

Actuatable assembly 205 displaces fluid 230 contained within tube 225,which can be a flexible line. Fluid 230 occupies expression reservoir250 within breast interface 235 a and is coupled with expandablemembrane 245 a. The expandable membrane 245 a is movable so as to movetoward and away from the breast as the actuatable element 215 isactuated. When a breast is engaged into and fluidly sealed with breastinterface 235 a by the flange 236, displacement of the actuatableelement 215 in the outward direction away from the breast producessubstantial vacuum pressure against the breast through expandablemembrane 245 a, resulting in the expression of breast milk intoexpression area 260. The expressed milk drains through drain port 265into collection vessel 275. Drain port 265 is configured with a one-wayvalve 280 to provide passage of milk while maintaining vacuum pressurein expression area 260.

The fluid for the hydraulic pumping device can be any suitable fluid,such as an incompressible fluid. In many embodiments, the incompressiblefluid can be water or oil. Alternatively, the fluid can be any suitablegas, such as air. Suitable incompressible fluids and gases for hydraulicsystems are known to those of skill in the art.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the hydraulic pumping device can becombined or substituted with components and features of any of theembodiments of the present invention as described herein.

Peristaltic Pump

In previous hydraulic pump embodiments, the hydraulic fluid in thepumping mechanism is often the same fluid used in the transmission linesand also in the breast interface. It can be advantageous to separate thefluids to prevent contamination, so that various components of thesystem may be more easily separated from one another, and also to avoidhaving to prime the pump or other components with fluid prior to use. Analternative embodiment of a pumping device that addresses some of thesechallenges uses a peristaltic pump device to move fluid to or from thebreast interface device.

FIG. 16 illustrates an exemplary embodiment of a peristaltic pump system1602 for expression of breast milk. The system 1602 preferably includestwo breast interfaces 1612, a transmission line or tubing 1608 and aperistaltic pump 1604. The breast interfaces 1612 may be any of theembodiments disclosed herein or known in the art. A transmission line ortubing 1608 is coupled to both breast interfaces. A preferablyincompressible fluid 1610 is disposed in tubing 1608. This embodimentillustrates two breast interfaces 1612, however one of skill in the artwill appreciate that a single breast interface or multiple breastinterfaces may be used. The peristaltic pump includes one or morerollers 1614 that engage tubing 1608. When the rollers move in a firstdirection, fluid 1610 is moved in a first direction toward one of thetwo breast interfaces and away from the remaining breast interface. Thisresults in actuation of the flexible membrane in the breast interfaces.One membrane is displaced outwardly thereby creating a vacuum in thebreast interface and allowing expression of breast milk. The othermembrane is displaced inwardly thereby either returning pressure tonormal pressure such as atmospheric pressure in the breast interface, ora positive pressure may be applied in the breast interface. When normalatmospheric pressure exists in the breast interface, the expressed milkcan then be collected as previously described. Or when a positivepressure is applied, the expressed milk may be forced out of the breastinterface into a collection container. One advantage of using aperistaltic pump with two breast interfaces is that while one side isexpressing milk, the other side is collecting the milk in a container.The pump 1604 may include any of the display features or communicationfeatures 1606 described elsewhere in this application.

FIG. 17 illustrates a partial cross-section of the peristaltic pump inFIG. 16. Tubing 1608 is positioned in a tight channel between therollers 1614 and an outer rim 1710 of pump 1604. As drive wheel 1708rotates, rollers 1614 compress tubing 1608 thereby displacing fluid 1610in the direction of rotation. Thus, in the embodiment of FIG. 17, thedrive wheel 1708 is rotating in a clock-wise direction and thus fluid1610 will be displaced from left to right side of the tubing andpositive pressure will be formed in breast interface 1612 a andexpandable membrane 1706 will be pushed outward toward the breast. Fluid1608 will move away from breast interface 1612 b thereby creating avacuum and membrane 1704 will move inward toward the back of the breastinterface. The negative pressure will then permit expression of breastmilk. The drive wheel 1708 may be a full circular wheel as indicated inphantom, or it may be a partial circle. One or more rollers 1614 maybecoupled to the wheel.

FIG. 18 illustrates another exemplary embodiment of a peristaltic pump1604 with the tubing uncoupled from the rollers 1614. This embodiment ofa pump system 1802 is substantially the same as the previous embodimentin FIGS. 16-17 with the major difference being that the tubing 1610 hasvarying compliance regions. Tubing 1610 may have a central compliantregion 1806 designed for engagement with the rollers 1614 and stiffer,less compliant regions 1804 on either side of the compliant region 1806.The compliant region 1804 allows the tubing to be compressed an easilyinserted into engagement with the rollers 1614. Additionally, when therollers roll over the complaint region, the tubing conforms to therollers and this facilitates transmission of the fluid 1610 along thetubing. The other portions 1804 are more rigid in order to transmit thepressure along the tubing.

Actuation Mechanism

Many actuation mechanisms known to those of skill in the art can beutilized for the actuatable assembly 205. Actuatable assembly 205 can bea piston assembly, a pump such as a diaphragm pump, or any othersuitable actuation mechanism. The optimal configuration for actuatableassembly 205 can depend on a number of factors, such as: vacuumrequirements; size, power, and other needs of the pumping device 200;and the properties of the fluid 230, such as viscosity,biocompatibility, and fluid life requirements.

FIGS. 3A and 3B illustrate exemplary embodiments in which actuatableassembly 205 is a piston assembly and driving element 215 is a piston.Actuatable assembly 205 includes radial seals 220, such as o-rings,sealing against assembly housing 210 to prevent undesired egress offluid 230 and to enable driving of fluid 230.

FIG. 4 illustrates another exemplary embodiment of an actuatableassembly 300 including a pair of pistons 305.

In preferred embodiments, the actuatable assembly includes a drivingelement powered by a suitable driving mechanism, such as a drivingmechanism residing in pendant unit 115. Many driving mechanisms areknown to those of skill in the art. For instance, the driving element,such as driving element 215, may be actuated electromechanically by amotor, or manually by a suitable user-operated interface, such as alever. Various drive modalities known to those of skill in the art canbe used. In particular, implementation of the exemplary hydraulicpumping devices as described herein enables the use of suitable drivemodalities such as direct drive and solenoids, owing to the reducedforce requirements of hydraulic systems.

Referring now to the exemplary embodiment of FIG. 4, the pistons 305include couplings 310 to a crankshaft 315. The crankshaft 315 isoperatively coupled to a motor 320 through a belt drive 325. Thecrankshaft 315 drives the pair of pistons 305 with the same stroketiming in order to apply vacuum pressure against both breastssimultaneously, a feature desirable for increased milk production.Alternatively, the crankshaft 315 can drive the pair of pistons 305 withany suitable stroke timing, such as alternating or offset stroke cycles.

The driving mechanism can be powered by any suitable power source, suchas a local battery or an AC adaptor. The driving mechanism can becontrolled by hardware, such as onboard electronics located withinpendant unit 115.

FIGS. 5A-5B illustrate an exemplary embodiment of an actuatable assembly350 that includes releasable coupling 355. FIG. 5A is a perspective viewof the embodiment, and FIG. 5B is a cross-sectional view of theembodiment. Preferably, actuatable assembly 350 is releasably coupled toa pendant unit 360 and the driving mechanism housed therein. Thecoupling can be a mechanical coupling or any suitable quick releasemechanism known to those of skill in the art. The releasably coupleddesign allows for flexibility in the configuration and use of thepumping device. For instance, user comfort can be improved through theuse of differently sized breast interfaces for compatibility withvarious breast sizes. Additionally, this feature enables a commonpumping device to be used with interchangeable breast interfaces, thusreducing the risk of spreading pathogens. Furthermore, the releasablecoupling enables easy replacement of individual parts of the pumpingdevice.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the actuation mechanism can becombined or substituted with components and features of any of theembodiments of the present invention as described herein.

Expandable Membrane

In many embodiments such as the embodiment depicted in FIG. 3B, theexpandable membrane 245 a is located within breast interface 235 a anddisposed over at least a portion thereof, forming expression reservoir250 between the interface housing 240 and the expandable membrane 245 a.Preferably, the expandable membrane 245 a comprises a resilient materialthat deforms substantially or a more rigid material that is displacedwhen subject to the negative pressures created when the fluid 230 isdisplaced from expression reservoir 250 by actuatable assembly 205. Theexpandable membrane returns to an unbiased position when the negativepressures subside. The amount of deformation of the expandable membrane245 a can be controlled by many factors, (e.g., wall thickness,durometer, surface area) and can be optimized based on the pumpingdevice (e.g., pump power, vacuum requirements).

FIG. 6 illustrates an exemplary expandable membrane 370 with a specifiedthickness and durometer.

FIG. 7 illustrates another embodiment of expandable membrane 375 withcorrugated features 380 for increased surface area. Other configurationsof the expandable membrane which may be used in any of the embodimentsof breast pumps described herein are disclosed in U.S. PatentProvisional Application No. 62/021,597 (Attorney Docket No.44936-706.101) filed Jul. 7, 2014; the entire contents of which areincorporated herein by reference.

Suitable materials for the expandable membrane are known to those ofskill in the art. In many embodiments, the expandable membrane can bemade of a material designed to expand and contract when subject topressures from the coupling fluid such as silicone, polyether blockamides such as PEBAX, and polychloroprenes such as neoprene.Alternatively, the expandable membrane can be fabricated from asubstantially rigid material, such as stainless steel, nitinol, highdurometer polymer, or high durometer elastomer. In these embodiments,the rigid material would be designed with stress and/or straindistribution elements to enable the substantial deformation of theexpandable membrane without surpassing the yield point of the material.

FIGS. 8A and 8B illustrate preferred embodiments of a breast interface400 in which an exit valve 405 is integrated into the expandablemembrane 410 to control the flow of expressed milk through exit port415. The exit valve 405 is opened to allow fluid flow when theexpandable membrane 410 is relaxed, as shown in FIG. 8A, and is closedto prevent fluid flow when the expandable membrane 410 is deformed, asshown in FIG. 8B. The exit valve 405 enables substantial vacuum pressureto be present in expression area 420 during extraction, while allowingmilk to drain during the rest phase of the pump stroke. While manyconventional breast pump valves function on pressure differentialsalone, the exit valve 405 can preferably be configured to also functionon the mechanical movement of expandable membrane 410. Incorporation ofan integrated exit valve 405 with mechanical functionality as describedherein can improve the sealing of the breast interface 400 during vacuumcreation. Furthermore, the implementation of an exit valve integrallyformed within the expandable membrane 410 such as exit valve 405 reducesthe number of parts to be cleaned.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the expandable membrane can becombined or substituted with components and features of any of theembodiments of the present invention as described herein.

Milk Collection and Quantification System

With reference to FIG. 3B, expressed milk drains through exit port 265in expandable membrane 245 a into a collection vessel 275. Collectionvessel 275 can be any suitable container, such as a bottle or a bag. Inmany embodiments, collection vessel 275 is removably coupled toexpandable membrane 245 a. Collection vessel 275 can be coupled directlyor remotely via any suitable device such as extension tubing.

In many instances, it can be desirable to track various data related tomilk expression and collection, such as the amount of milk production orthe chemical and nutritional content of the produced milk. Currently,the tracking of milk production is commonly accomplished by manualmeasurements and record-keeping. Exemplary embodiments of the devicedescribed herein may provide digital-based means to automaticallymeasure and track milk production for improved convenience, efficiency,and accuracy.

FIGS. 9A and 9B illustrate exemplary embodiments of a breast interface450 with one or more integrated sensors 455. Sensors 455 are preferablylocated in flap valve 460, but may also be located in exit valve 465, orany other suitable location for monitoring fluid flow. In a preferredembodiment, at least one sensor 455 is integrated into a valve that isopened by fluid flow and detects the length of time that the valve isopened. The sensor signal can be interrogated to quantify the fluidflow. Suitable sensors are known to those of skill in the art, such asaccelerometers, Hall effect sensors, and photodiode/LED sensors. Thebreast interface can include a single sensor or multiple sensors toquantify milk production.

FIG. 10 illustrates an exemplary embodiment of pendant unit 500 in whichmilk expression data is shown on a display screen 505. In manyembodiments, the pendant unit 500 collects, processes, stores, anddisplays data related to milk expression. Preferably, the pendant unit500 can transmit the data to a second device, such as a mobile phone510.

FIG. 11 illustrates data transmission 515 between pendant unit 500 and amobile phone 510. Suitable methods for communication and datatransmission between devices are known to those of skill in the art,such as Bluetooth or near field communication.

In exemplary embodiments, the pendant unit 500 communicates with amobile phone 510 to transmit milk expression data, such as expressionvolume, duration, and date. The mobile phone 510 includes a mobileapplication to collect and aggregate the expression data and display itin an interactive format. Preferably, the mobile application includesadditional features that allow the user to overlay information such aslifestyle choices, diet, and strategies for increasing milk production,in order to facilitate the comparison of such information with milkproduction statistics. The mobile application can also include featuresthat allow the user to control aspects of the pump, such as pump powerand pump states (e.g., let-down and stimulate modes), adjust expressionpressure and speed, and adjust the size of the breast interface 235 a orothers described herein, where the breast interface is automaticallyadjustable. The application may also have resources for breastfeedingmoms, such as advice or connection to advice, social aspects such aspeer comparisons, and an accessory store for acquiring accessories forthe pump. Additionally, the pendant unit 500 can send information aboutthe times of pump usage to the mobile phone 510 so that the mobileapplication can identify when pumping has occurred and set reminders atdesired pumping times. Such reminders can help avoid missed pumpingsessions, and thus reduce the incidence of associated complications suchas mastitis.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the milk collection andquantification system can be combined or substituted with components andfeatures of any of the embodiments of the present invention as describedherein.

Mechanical Pumping Device

FIG. 12 illustrates an alternative embodiment of a breast interface 600in which a mechanical deformable member 605 can be used in place of aflexible membrane 245 or expandable membrane 245 a. The mechanicaldeformable member 605 can be constructed from similar techniques asthose used for the flexible or expandable membrane as described herein.The mechanical deformable member 605 is coupled to a tensile element610. In some instances, tensile element 610 is disposed within an axialload absorbing member 615. The axial load absorbing member 615 isdisposed within tube 620. Preferably, tensile element 610 isconcentrically disposed within axial load absorbing member 615 and axialload absorbing member 615 is concentrically disposed within tube 620.Alternative arrangements of tensile element 610, axial load absorbingmember 615, and tube 620 can also be used.

FIG. 13 illustrates the tensile element 610 coupled to driving element625 of an actuatable assembly 630 within an assembly housing 635.Driving element 625 is operatively coupled to a driving mechanism, suchas a driving mechanism housed within a pendant unit, through shaft 640.Axial load absorbing member 615 within tube 620 is fixedly coupled tothe assembly housing 635. Displacement of the driving element 625transmits tensile force through tensile element 610 to the mechanicaldeforming member 605 to create vacuum pressure against the breast.

The tensile element 610 can be any suitable device, such as a wire,coil, or rope, and can be made from any suitable material, such asmetals, polymers, or elastomers. Axial load absorbing member 615 can bemade from any suitable axially stiff materials, such as metals orpolymers, and can be configured into any suitable axially stiffgeometry, such as a tube or coil.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the mechanical pumping device can becombined or substituted with components and features of any of theembodiments of the present invention as described herein.

Adjustable Breast Interface

Referring to the exemplary embodiment of FIG. 3B, the breast interface235 a or any other embodiment described herein may be adjustable in sizeor shape to fluidly seal against and perform efficiently with aplurality of sizes or shapes of human breast. In some embodiments, theflange 236 may be adjustable in one or both of the frustoconical portion237 and the inner diameter of the tubular flange neck 238, so as toadjust the size or shape of the breast interface. In some embodiments,the expression area 260 may be adjustable in size or shape, including inthe size of the expression mouth 261, so as to adjust the size or shapeof the breast interface and improve the efficiency of milk expression.Yet other embodiments may comprise a combination of an adjustable flangeand an adjustable expression area.

FIG. 19A is a cross-sectional view of an exemplary embodiment of anadjustable flange 1900. A flange includes a tapered or frustoconicalportion 1905 that engages the breast, and a tubular flange neck 1915 onthe opposite end that transitions into expression area 1920 of thebreast interface 1910 through the expression mouth 1921. The flange hasan exterior surface 1925 and an interior surface 1930 with a wall 1935defined therebetween. Physical properties and construction of the wall1935 may vary in different embodiments, allowing the thickness of thewall to be adjusted so as to adjust the size of the flange 1910 to fit aparticular size or shape of breast. The flange 1910 may be sized fixedlyor adjustably, and flanges of various fixed or adjusted sizes may bedetachable from or integrated with the breast interface 1910. Thethickness of the wall 1935 may vary in different embodiments.

FIGS. 19B and 19C illustrate exemplary embodiments of adjustable flanges1901 and 1902 of different sizes. Whereas the flange 1900 in FIG. 19Ahas a wall 1935 of a thickness such that the inner diameter of flangeneck 1915 is about 30 mm, the flange 1901 in FIG. 19B has a wall 1936thicker than wall 1935 such that the inner diameter of the flange neck1906 is about 27 mm. The flange 1907 in FIG. 19C has a wall 1937 thickeryet than wall 1936, such that the inner diameter of the flange neck 1907is about 24 mm. One of skill in the art will appreciate that thesedimensions are not limiting, and that any size is possible.

FIGS. 20A and 20B are perspective views of an exemplary embodiment of anadjustable flange 2000 with a sizing element 2005. The sizing element2005 may be a fully closed ring or a partial ring, which encircles theengagement region 2010 disposed on the flange neck 2015, therebydecreasing or increasing the inner diameter of flange neck. The sizingelement 2005 may be releasably coupled to the engagement region 2010 byany one of several mechanisms well-known in the art, such as a snap fit,press fit, or magnetic engagement mechanism. The sizing element 2005 maybe provided in various sizes, all of which are releasably coupleable tothe engagement region 2010 in the same manner. The sizing element 2005can be coupled to and released from the engagement region 2010repeatedly, so as to allow the flange 2000 to be adjustable in sizethroughout the course of a user's use of the breast milk expressiondevice. FIG. 20A shows the sizing element 2005 coupled to the flange2000, while FIG. 20B shows the sizing element 2005 released from theflange 2000.

FIGS. 21A, 21B, and 21C are cross-sectional views of an exemplaryembodiment of an adjustable flange 2100 with a sizing element. Sizingelements 2105 and 2106 can be releasably coupled to the engagementregion 2110, which may comprise a compliant material that is reversiblydeformed when a sizing element 2105 or 2106 is coupled. The deformationof the engagement region 2110 can result in the narrowing of the flangeneck 2115 so as to adjust the size of the flange 2100 to fluidly sealagainst a particular size or shape of human breast. The release of acoupled sizing element 2105 or 2106 can reverse the deformation of theengagement region 2110, resulting in the widening of the flange neck2115. FIG. 21A shows the adjustable flange 2100 with no coupled sizingelement, having a flange neck 2115 with an inner diameter of about 30mm. FIG. 21B shows the flange 2100 with sizing element 2105 coupled tothe engagement region 2110, resulting in the narrowing of the flangeneck 2115 such that the inner diameter of the flange neck decreases toabout 27 mm. FIG. 21C shows the flange 2100 with sizing element 2106coupled to the engagement region 2110, resulting in the furthernarrowing of the flange neck 2115 such that the inner diameter of theflange neck decreases to about 24 mm. The sizing element may be a ring,split ring, or other clip such as those previously described.

FIGS. 22A, 22B, and 22C illustrate exemplary embodiments of anadjustable flange 2200 that comprises a fillable pocket 2205. The pocket2205 may be disposed between the interior surface 2206 and exteriorsurface 2207 of the flange 2200 or the pocket may be a discretereservoir on an interior or exterior surface of the flange. The pocket2205 comprises a material that prevents any filling material fromleaking out. Filling of the pocket 2205 with a filling materialdisplaces the interior surface of the flange 2200 towards the breast tobetter seal against the surface of the breast and also to narrow theflange neck 2210. The filling of the pocket 2205 can be reversible, suchthat the removal of a filling material from a filled pocket 2205 resultsin the widening of the flange neck 2210. Preferably, the pocket 2205 maybe filled or emptied repeatedly, so as to allow the flange 2200 to beadjustable in size throughout the course of a user's use of the breastmilk expression device. The pocket 2205, whether filled or emptied, doesnot obstruct the flange 2200 from forming a fluid seal against thebreast.

The pocket 2205 can be accessed for filling with a filling material byvarious means, depending on the physical and chemical properties of thefilling material. As shown in FIG. 22B, the pocket 2205 may comprise aflexible material 2215 that can be punctured without being permanentlydeformed, such as a butyl rubber or other elastomer, thereby allowingthe addition or removal of a filling material through a sharp apparatussuch as a needle 2220. Alternatively, as shown in FIG. 22C, the pocket2205 may comprise an access port 2225 such as a cap 2230 that can beopened or closed mechanically, disposed on the surface of the pocket2205, through which the filling material may be added or removed.

FIG. 22D is a cross-sectional view of an exemplary embodiment of anadjustable flange 2250 with a pocket 2255 filled with a fluid 2260.Filling of the pocket 2255 with the fluid 2260 displaces the interiorsurface 1956 of the flange 2250 towards the breast to better sealagainst the surface of the breast and also to narrow the flange neck2210. The fluid 2260 may comprise any suitable material, such as asaline solution or other fluids including gases. Adding the fluid 2260to or removing the fluid from the pocket 2255 can adjust the size of theflange 2250 to fit a particular size or shape of human breast.

FIG. 22E is a cross-sectional view of an exemplary embodiment of anadjustable flange 2280 with a pocket 2285 filled with a plurality ofbead-like elements 2290. The plurality of bead-like elements 2290 maycomprise any suitable material, such as polystyrene beads or silicananoparticles. The pocket 2285 can be filled with the plurality ofbead-like elements 2290, then molded against the user's breast. Once thepocket 2285 with the bead-like elements 2290 is disposed against thebreast and molded therearound, application of a vacuum to the filledpocket 2285 can lock the plurality of bead-like elements 2290 into afixed configuration for fluidly sealing against a particular size orshape of human breast. This concept is well known in the art and issometimes referred to as dilatancy.

FIGS. 23A and 23B illustrate another exemplary embodiment of anadjustable flange 2300 comprising a fillable pocket 2305. The pocket2305 is fluidly coupled to the air pump 2310 and the exhaust valve 2315.The air pump comprises a vault 2320 having an integrated valve, suchthat the valve closes when the vault is compressed and opens when thevault expands. The air pump also comprises an inlet valve 2325 whichfluidly couples the vault 2320 with the pocket 2305. When vault 2320 isdepressed, air flows from the vault into the pocket 2305 through theinlet valve 2325. Inlet valve 2325 is a check valve, such as a duckbillvalve, that allows air to flow in one direction only, from the vault tothe pocket. A secondary relief valve, separate from or integrated withvalve 2325, may be configured to release excessive pressure in thepocket 2305. The exhaust valve 2315 is configured to be in a closedposition by default, for example by means of a spring mechanism. Whendepressed, the exhaust valve opens, allowing air to flow out from thepocket 2305, through the exhaust valve. FIG. 23A shows the pocket 2305in the empty configuration, while FIG. 23B shows the pocket filled withair, whereby the interior surface 2330 of the flange is displacedtowards the breast and the flange neck 2335 is narrowed. Adding air toor removing air from the pocket 2305 can adjust the size of the flange2300 to fit a particular size or shape of human breast.

FIGS. 24A and 24B illustrate an exemplary embodiment of a device 2400for expressing breast milk comprising an adjustable expression area2402. The device further comprises an adjustable reservoir 2405 in fluidcommunication with an actuatable assembly 2410, which is operativelycoupled by tube 2415 to the breast interface 2420. The breast interfacecomprises an expandable membrane 2425 and an expression reservoir 2440,which is fluidly coupled by tube 2415 to the adjustable reservoir 2405and the actuatable assembly 2410.

The actuation of the actuatable assembly 2410 delivers the fluid 2435from the adjustable reservoir 2405 through the tube 2415 to theexpression reservoir 2440, and returns the fluid 2435 from theexpression reservoir through the tube to the adjustable reservoir. Thechange in the volume of fluid in the expression reservoir causes theexpandable membrane 2425 to expand or collapse, thereby adjusting thesize of the expression area 2402. The volume of fluid 2435 in theadjustable reservoir can be adjusted so as to adjust the volume of thefluid in the expression reservoir. When the volume of fluid in theexpression reservoir decreases, the expandable membrane 2425 expands andmoves closer to the interface housing 2421, thereby increasing the sizeof the expression area 2402. FIG. 24A shows the device whereby theadjustable reservoir 2405 contains a small volume of fluid and theexpression reservoir 2440 contains a corresponding larger volume offluid, thereby resulting in a smaller expression area 2402. FIG. 24Bshows the device whereby the adjustable reservoir 2405 contains a largevolume of fluid and the expression reservoir 2440 contains acorresponding smaller volume of fluid, thereby resulting in a largerexpression area 2402. Adjusting the size of the expression area 2402 canadjust the size of the breast interface 2420 to fluidly seal against aparticular size or shape of human breast.

The volume of fluid in the adjustable reservoir 2405 may be adjustedmanually by various means. For example, the adjustable reservoir 2405may comprise threaded walls 2406 and a threadably engaged plug 2407,such that turning the plug increases or decreases the volume of fluid inthe adjustable reservoir.

The volume of fluid in the adjustable reservoir 2405 may also beadjusted automatically, whereby the device 2400 comprises a closed-loopsystem that is capable of sensing the engagement of the breast interfacewith the breast and accordingly adjusting the volume of fluid in theadjustable reservoir to adjust the size of the expression area 2402.FIG. 25 illustrates an exemplary embodiment of an automaticallyadjustable system for adjusting the size of the expression area. Amobile phone 2500 may be in communication with a pendant unit 2501 thatcontrols the breast milk expression device. The device may operate inseveral different states, such as pumping state 2502 and adjustmentstate 2503. The phone can put the pendant unit into an adjustment state,which drives the motor 2505, disposed within the actuatable assembly,for adjustment of the volume of fluid in the expression reservoir 2510.The adjustable reservoir 2515 may be integrated with and in fluidcommunication with the actuatable assembly, such that the volume offluid in the expression reservoir may be adjusted by changing a settingof the actuatable assembly. For example, the actuatable assembly maycomprise a piston assembly in fluid communication with the expressionreservoir, and the piston may be set at a preset resting position so asto result in a preset volume of fluid in the expression reservoir.Changing the resting position of the piston can accordingly increase ordecrease the volume of fluid the expression reservoir. An adjustablereservoir integrated with the actual assembly in this manner, comparedto a separate adjustable reservoir, can reduce the number of parts inthe system as well as simplify the adjustment operation. The motor maysteadily increase the volume of fluid in the expression reservoir,providing motor current feedback to the pendant unit. The motor currentfeedback may be used to determine when the breast interface has fluidlysealed against the breast, by sensing the timepoint at which the motorcurrent begins to rise in response to greater resistance in the system.When the pendant unit receives feedback that the breast interface hassealed against the breast, it may end the adjustment state. Preferably,the volume of fluid in the adjustable reservoir may be reset to aninitial default value at any point, so that a user may readjust the sizeof the expression area as necessary.

One of skill in the art will appreciate that components and features ofany of the exemplary embodiments of the adjustable breast interface canbe combined or substituted with components and features of any of theembodiments of the present invention as described herein.

Experimental Data

FIGS. 14 and 15 illustrate experimental pumping data obtained from acommercial breast pump device and an exemplary embodiment of the presentinvention. The exemplary embodiment utilized an incompressible fluid forpumping and had a maximum hydraulic fluid volume of 4 cc, while thecommercial device utilized air for pumping and had a maximum volume of114 cc.

FIG. 14 illustrates a graph of the pump performance as quantified byvacuum pressure generated per run. For the exemplary embodiment,pressure measurements were taken for 1 cc, 2 cc, 3 cc, and 4 cc of fluidvolume displaced by the pump, with the run number corresponding to thevolume in cc. For the commercial device, measurements were taken withthe pump set to one of seven equally incremented positions along thevacuum adjustment gauge representing 46 cc, 57 cc, 68 cc, 80 cc, 91 cc,103 cc, and 114 cc of fluid volume displaced by the pump, respectively,with the run number corresponding to the position number. Curve 700corresponds to the exemplary embodiment and curve 705 corresponds to thecommercial device. The exemplary embodiment generated higher levels ofvacuum pressure per displacement volume compared to the commercialdevice, with maximum vacuum pressures of −240.5 mmHg and −177.9 mmHg,respectively.

FIG. 15 illustrates a graph of the pump efficiency as measured by themaximum vacuum pressure per maximum volume of fluid displaced, with bar710 corresponding to the exemplary embodiment and bar 715 correspondingto the commercial device. The exemplary embodiment demonstrated a42-fold increase in pumping efficiency compared to the commercialdevice, with efficiencies of −71.1 mmHg/cc and −1.7 mmHg/cc,respectively.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A device for expression and collection of breastmilk, said device comprising: a breast interface configured to engage abreast and fluidly seal thereagainst, the breast interface having amovable member disposed within at least a portion thereof; a tube filledwith fluid and fluidly coupled with the breast interface; and aperistaltic pump coupled with the tube, wherein actuation of theperistaltic pump moves the fluid in a first direction or a seconddirection opposite the first direction, and wherein movement of thefluid in the first direction moves the movable member in the breastinterface in the first direction and thereby causes the breast interfaceto apply vacuum pressure at the breast to express milk therefrom, andwherein movement of the fluid in the second direction moves the movablemember in the breast interface in the second direction and therebyapplies pressure at the breast interface.
 2. The device of claim 1,wherein the peristaltic pump is removably coupled with the tube.
 3. Thedevice of claim 1, wherein the movable member of the breast interfacecomprises one or more of a flexible membrane, a deformable portion of asealing element coupled to a flexible membrane, or an expandablemembrane, configured to move in response to actuation of the peristalticpump.
 4. The device of claim 1, wherein movement of the movable memberin the second direction returns the breast interface to atmosphericpressure, thereby allowing the expressed milk to drain into a collectionvessel coupled to the breast interface.
 5. The device of claim 1,wherein the device further comprises a collection vessel fluidly coupledto the breast interface, and wherein movement of the movable member inthe second direction applies positive pressure at breast interface,thereby forcing the expressed milk out of breast interface into thecollection vessel.
 6. The device of claim 1, wherein the device furthercomprises a collection vessel fluidly coupled to the breast interface,and wherein the breast interface comprises a first breast interfaceconfigured to engage a first breast and a second breast interfaceconfigured to engage a second breast, and wherein actuation of theperistaltic pump simultaneously causes the first breast interface toexpress milk from the first breast and the second breast interface tocollect expressed milk from the second breast into the collectionvessel.
 7. The device of claim 1, wherein the tube comprises a centralcompliant region configured to engage the peristaltic pump and a lesscompliant region that is less compliant relative to the centralcompliant region disposed adjacent to the central compliant region, suchthat the central compliant region compresses in response to actuation ofthe peristaltic pump, while the less compliant region transmits pressurealong the tube to the breast interface.
 8. A method for expressing milkfrom a breast, said method comprising: engaging and fluidly sealing abreast interface with the breast; actuating a peristaltic pump coupledwith a tube filled with a fluid and fluidly coupled to the breastinterface, thereby applying vacuum pressure at the breast; andexpressing milk from the breast.
 9. The method of claim 8, whereinactuating a peristaltic pump comprises actuating the peristaltic pump soas to move the fluid in a first direction or in a second directionopposite the first direction, wherein moving the fluid in the firstdirection causes a movable member within the breast interface to moveaway from the breast and thereby apply vacuum pressure at the breast toexpress milk therefrom, and wherein moving the fluid in the seconddirection causes the movable member to move toward the breast andthereby causing the expressed milk to drain into a collection vesselfluidly coupled to the breast interface.
 10. The method of claim 9,wherein moving the fluid in the second direction returns the breastinterface to atmospheric pressure, thereby allowing the expressed milkto drain into the collection vessel.
 11. The method of claim 9, whereinmoving the fluid in the second direction applies a positive pressure atbreast interface, thereby forcing the expressed milk out of the breastinterface into the collection vessel.
 12. The method of claim 8, whereinthe breast interface comprises a first breast interface configured toengage a first breast and a second breast interface configured to engagea second breast, and wherein actuating a peristaltic pump comprisessimultaneously moving the fluid away from the first breast interface toexpress milk from the first breast, and moving the fluid toward thesecond breast interface to collect expressed milk from the second breastinto a collection vessel fluidly coupled to the second breast interface.13. A device for expressing breast milk from a breast, said devicecomprising: a breast interface comprising a flange configured to engageand fluidly seal against the breast, and an expression area where milkis expressed from the breast; wherein the breast interface is manuallyor automatically adjustable to fluidly seal against a plurality of sizesor shapes of breasts.
 14. The device of claim 13, wherein the flangecomprises one or more resilient materials conformable to the breast andadapted to fluidly seal against the plurality of sizes or shapes ofbreasts.
 15. The device of claim 13, wherein the flange comprises apocket fillable with a filling material, and wherein addition of fillingmaterial to, or removal of the filling material from the pocket adjustsa size of the flange.
 16. The device of claim 15, wherein the fillingmaterial comprises a plurality of bead-like elements, and whereinapplication of a vacuum to the pocket substantially locks the pluralityof bead-like elements and the flange into a fixed configuration forfluidly sealing against a particular size or shape of human breast. 17.The device of claim 15, wherein the filling material comprises a fluid.18. The device of claim 17, wherein the breast interface furthercomprises a fluid pump fluidly coupled to the pocket, the fluid pumpconfigured to add or remove the fluid from the pocket.
 19. The device ofclaim 13, wherein the device further comprises an actuatable assemblyoperatively coupled to the breast interface; an expression reservoirdisposed within the breast interface; and an adjustable reservoirfluidly coupled to the expression reservoir and operatively coupled tothe actuatable assembly; wherein the actuatable assembly is configuredto deliver fluid from the adjustable reservoir to the expressionreservoir or remove fluid from the expression reservoir and return thefluid to the adjustable reservoir, and wherein the adjustable reservoircomprises a mechanism to adjust a volume thereof, so as to adjust avolume of the expression reservoir and thereby adjust a size of theexpression area to fluidly seal against a particular size or shape ofbreast.
 20. The device of claim 19, wherein the mechanism is manuallyadjustable.
 21. The device of claim 19, wherein the mechanism isautomatically adjustable to adjust the volume of the adjustablereservoir in response to a feedback from the actuatable assemblyindicating a degree of fluid seal between the breast interface and thebreast.
 22. The device of claim 21, wherein the feedback comprises acurrent produced by the actuatable assembly as the volume of theadjustable reservoir is adjusted, wherein an increase in the currentindicates an increased degree of fluid seal between the breast interfaceand the breast.
 23. The device of claim 21, wherein the adjustablereservoir is integrated with the actuatable assembly, such that thevolume of the adjustable reservoir may be adjusted by changing a settingof the actuatable assembly.
 24. The device of claim 23, wherein theactuatable assembly comprises a piston assembly and wherein theadjustable reservoir comprises a reservoir of the piston assembly, suchthat changing a resting position of the piston assembly adjusts thevolume of fluid in the adjustable reservoir.
 25. A method for expressingbreast milk from a breast, said method comprising: providing a devicefor expressing breast milk comprising an adjustable breast interfacehaving a flange and an expression area; engaging the adjustable breastinterface with the breast; adjusting a size of the adjustable breastinterface; fluidly sealing the breast interface against the breast; andexpressing milk from the breast.
 26. The method of claim 25, whereinadjusting the size of the adjustable breast interface comprises adding afluid to or removing the fluid from a pocket disposed within the flange.27. The method of claim 25, wherein adjusting the size of the adjustablebreast interface comprises: providing a plurality of bead-like elementsdisposed in a pocket in the flange; molding the plurality of bead-likeelements against the human breast; applying a vacuum to the pocket; andlocking the flange into a particular size or shape.
 28. The method ofclaim 25, wherein the breast interface comprises an expression reservoirfluidly coupled with an actuatable assembly and an adjustable reservoir,and wherein adjusting the size of the adjustable breast interfacecomprises: actuating the actuatable assembly, thereby delivering a fluidfrom the adjustable reservoir to the expression reservoir or removingthe fluid from the expression reservoir and returning the fluid to theadjustable reservoir; and adjusting a volume of the adjustable reservoirso as to adjust a volume of the expression reservoir, thereby adjustinga size of the expression area.
 29. The method of claim 28, whereinadjusting a volume of the adjustable reservoir comprises manuallyadjusting the volume of the adjustable reservoir.
 30. The method ofclaim 28, wherein adjusting a volume of the adjustable reservoircomprises automatically adjusting the volume of the adjustable reservoirin response to a feedback from the actuatable assembly indicating adegree of fluid seal between the breast interface and the breast. 31.The method of claim 30, wherein the adjustable reservoir is integratedwith the actuatable assembly, and wherein automatically adjusting thevolume of the adjustable reservoir comprises changing a setting of theactuatable assembly.
 32. The method of claim 31, wherein the actuatableassembly comprises a piston assembly and wherein the adjustablereservoir comprises a reservoir of the piston assembly, and whereinautomatically adjusting the volume of the adjustable reservoir compriseschanging a resting position of the piston assembly.